Insulin Ria Kit
FDA 510(k) K781285 · Serono Laboratories, Inc.
510(k) numberK781285
Submission
- Device name
- Insulin Ria Kit
- Applicant
- Serono Laboratories, Inc.
Mchenry, IL, US - Received
- July 26, 1978
- Decision date
- August 14, 1978
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- CFP – Radioimmunoassay, Immunoreactive Insulin
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 862.1405
- Specialty
- Clinical Chemistry
Other 510(k)s with product code CFP
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K963911 | Alpco/Mercodia Insulin ElisaCFP · Traditional | American Laboratory Products Co., Ltd. | 11/01/1996SE |
| K953084 | Access Ultrasensitive Insulin AssayCFP · Traditional | Bio-Rad Laboratories, Inc. | 09/25/1995SE |
| K920109 | Imx InsulinCFP · Traditional | Abbott Laboratories | 05/07/1992SE |
| K914820 | DSL Insulin Ria (DSL 1600)CFP · Traditional | Diagnostic Systems Laboratories, Inc. | 01/09/1992SE |
| K903628 | Aia-Pack IriCFP · Traditional | Tosoh Corp. | 09/07/1990SE |
| K901135 | Enzymun Test(R) InsulinCFP · Traditional | Boehringer Mannheim Corp. | 04/03/1990SE |
| K896572 | Rep(Tm) Spe PLUS-30 ProceduresCFP · Traditional | Helena Laboratories | 01/11/1990SE |
| K890837 | Ria-Gnost InsulinCFP · Traditional | Cambridge Medical Technology | 04/26/1989SE |
| K851071 | Pharmacia Insulin RiaCFP · Traditional | Pharmacia, Inc. | 04/12/1985SE |
| K841573 | Insulin Radioimmunoassay KitCFP · Traditional | Sorin Biomedica, Fiat, USA, Inc. | 05/16/1984SE |
More from Sorin Biomedica, Fiat, USA, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K834428 | Aldosterone Radioimmunoassay Test KitCJM · Traditional | 03/02/1984SE |
| K810695 | Estriol Radioimmunoassay Test KitCHP · Traditional | 03/31/1981SE |
| K810625 | Human Placental Lactogen Radioimmuno-DHI · Traditional | 03/27/1981SE |
| K792043 | Pap-Check Ria KitJFH · Traditional | 10/30/1979SE |
| K790679 | Estradiol Ria KitCHP · Traditional | 05/23/1979SE |
| K790440 | ProgesteroneJLS · Traditional | 05/03/1979SE |
| K782143 | Ria Kit, GlucoseJME · Traditional | 02/22/1979SE |
| K782103 | Ria Kit, Neonatal T4CDX · Traditional | 01/17/1979SE |
| K781733 | Ria Kit, Preg-StatJHI · Traditional | 12/20/1978SE |
Questions and answers
When was Insulin Ria Kit cleared by the FDA?
Insulin Ria Kit (K781285) received a 510(k) decision of Substantially Equivalent on August 14, 1978, 19 days after the submission was received.
What is the product code of K781285?
The FDA product code is CFP – Radioimmunoassay, Immunoreactive Insulin, a Class I (low risk) device regulated under 21 CFR 862.1405.